Chronic Heart Failure
Conditions
Keywords
Denervation, Renal denervation, Heart failure, Ultrasound, Cardiovascular Diseases
Brief summary
The purpose is to evaluate the renal denervation system (PRDS-001) for controlling sympathetic nerve over-activation in patients with heart failure, and for its safety in such patients.
Interventions
Renal Denervation Ultrasound System
Sponsors
Otsuka Medical Devices Co., Ltd. Japan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
: * Patients aged 18 years or older and younger than 85 years at the time of informed consent * NYHA (New York Heart Association) class II-III * More than 6 weeks have passed since onset of acute heart failure or acute exacerbation of chronic heart failure * Washout rate of MIBG \[3 (meta)-iodobenzylguanidine\] scintigraphy-cardiac is more than 35% * Patients having continued treatment of heart failure with the same dosage and administration for 4 weeks before obtaining informed consent
Exclusion criteria
: * Patients with type1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (HbA1c: ≥ 8%) * Patients whose eGFR (estimated glomerular filtration rate) is less than 40 mL/min/1.73 m\^2 (estimation formula by Japanese Society of Nephrology) * Patients with concomitant or previous autoimmune or inflammatory bowel disease * Patients with a history of serious lung disease * Patients with a history of heart transplantation or VAD \[ventricle-assist device\] * Patients receiving reserpine, tricyclic antidepressants, and labetalol hydrochloride (can be used for up to 5 half-lives before informed consent is obtained) * Patients being treated for Parkinson's disease or Lewy body dementia * Patients with a history of any severe cardiovascular event (myocardial infarction, coronary artery bypass graft surgery, acute heart failure requiring hospitalization) or severe cerebrovascular event (stroke, transient ischemic event, cerebrovascular accident, etc.) within 3 months before obtaining informed consent * Patients with persistent atrial fibrillation * Patients using active implantable medical devices * Patients with coronary or carotid artery diseases who were deemed necessary by the principal investigator / sub investigator to undergo surgery or PCI (Percutaneous Coronary Intervention) within 6 months after obtaining informed consent * Patients with contraindications, unacceptable anaphylactic reactions, or uncontrollable allergies to contrast media * Female patients who are pregnant or breastfeeding * Patients whose office blood pressure (systolic) is 100mmHg or lower at the time of screening test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MIBG-cardiac(washout rate) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Peak load assessed by CPX | 6 months |
| Ramp duration assessed by CPX | 6 months |
| Urinary noradrenalin concentration | 6 months |
| NYHA class | 6 months |
| MIBG-renal (washout rate) | 6 months |
| MIBG-renal (early: kidney-to-mediastinum ratio (K/M), late: K/M) | 6 months |
| MIBG-cardiac(early; heart-to-mediastinum ratio (H/M), late: H/M) | 6 months |
| Anaerobic Threshold assessed by CPX (Cardiopulmonary Exercise Testing) | 6 months |
| Lowest minute ventilation (VE)/carbon dioxide output (VCO2) assessed by CPX | 6 months |
| Peak oxygen uptake (peak VO2) assessed by CPX | 6 months |
| Peak VO2/heart rate assessed by CPX | 6 months |
| Peak respiratory exchange ratio assessed by CPX | 6 months |
| VE-VCO2 slope assessed by CPX | 6 months |
Countries
Japan
Outcome results
None listed